Homotaurine-enriched compositions and methods of use for animal health

ABSTRACT

The present disclosure generally relates to compounds comprising homotaurine that may be used in improving the general mental condition and/or general brain function of a non-human animal, and for the prophylaxis of chronic, aging-related mental deterioration in non-human animals. In addition, the present disclosure generally relates to compositions comprising homotaurine that may be used in determining whether a candidate veterinary compound and/or a candidate formulation can improve general mental condition and/or general brain function of animals and for the prophylaxis of chronic, aging-related mental deterioration in non-human animals.

RELATED APPLICATION

This application claims priority to and benefit from Canadian PatentApplication CA 2,912,611, filed Nov. 18, 2015, the disclosure of whichis incorporated herein by reference in its entirety.

FIELD OF TECHNOLOGY

The present disclosure generally relates to compositions that may beused in improving the general mental condition and/or general brainfunction of a non-human animal, and for the prophylaxis of chronic,aging-related mental deterioration in non-human animals. In addition,the present disclosure generally relates to compositions that may beused in determining whether a candidate veterinary compound and/or acandidate formulation can improve general mental condition and/orgeneral brain function of non-human animals and for the prophylaxis ofchronic, aging-related mental deterioration in non-human animals.

BACKGROUND INFORMATION

Animals play an important role in many people's lives. In addition toseeing-eye dogs and dogs that can be trained to detect seizures, animalscan also be used in occupational therapy, speech therapy, or physicalrehabilitation to help patients recover. Aside from these designatedtherapeutic roles, animals are also valued as companions, which canaffect the quality of human lives. The pet industry in the United Statesand many other countries is booming. Americans, for example, own morepets than ever before. Growth in the sector is derived both fromincreasing pet ownership as well as from increased spending per pet. Petpampering is becoming the norm, as pet owner spending has moved farbeyond simple food and grooming expenses to include innovative andspecialized premium products and medical treatments. People increasinglyview their pets as part of the family and are willing to spend evenduring difficult economic times. According to the American Pet ProductAssociation (APPA), Americans spent approximately $47.7 billion on petproducts and services in 2010, an increase of 4.8% over 2009. Since1988, pet ownership has expanded from 56% of households to 62%.

Like people, animals (non-human animals) suffer from diseases andrequire proper care from the veterinarians, the farmers and the petowners. Keeping animals healthy and treating them with dignity is one ofthe main objectives of the animal health industry and applies equally tocompanion animals, livestock and wild animals.

Aging has long been associated with a gradual decline in memory,cognition and thinking abilities. Previously, the deterioration ofmemory, cognition and thinking abilities has been considered as anormal, unmodifiable process as a result of aging. Research as shownhowever, that this progression can be delayed and/or slowed, byimproving the overall protection of brain cells during the normal courseof aging.

Aging and a gradual decline in memory and cognitive functions is not amalady that is specific to humans only; it is also observed in non-humananimals, for example in companion animals such as in canines (e.g.,dogs) and felines (e.g., cats), and may occur in other non-human animalspecies. For example, Cognitive Dysfunction Syndrome (CDS) represents agroup of symptoms related to the aging of the canine and feline brain.Although the initial symptoms of CDS are mild, the symptoms graduallyworsen over time and are generally referred to as “cognitive decline”.In some canine breeds, and moreover in breeds of large dogs, the onsetand rapid progression of CDS is a well-known phenomenon and oftenresults in near to complete incapacitation of the affected animal.

Similar in its symptomology to Alzheimer's disease in humans,canine/feline cognitive dysfunction may be caused by physical andchemical changes in the brain that result in a progressive decline andloss of mental cognition in the affected animal. Studies have shown thatsome older dogs with cognitive dysfunction have brain lesions similar tothose that physicians see in Alzheimer's human patients. The result ofthese changes may be manifested by one or more of a number of CDSsymptoms such as aging-related behavioral changes in canines, and alsoin felines, including: frequent incidents of soiling while indoors or inareas other than where the animal has been trained and has perpetuallyutilized for such a purpose (e.g. the location of a litterbox for acat); a loss of stamina or chronic fatigue; it exhibits a lack offamiliarity with places either indoors or outdoors even though theanimal has been familiar with the location throughout its life;unfocused wandering and staring at walls or into space and becoming“trapped” behind familiar furniture or in room corners; the animaltrouble finding and using doors and negotiating stairways despite havingno apparent deterioration of its muscular co-ordination or eyesight; theanimal, although undistracted, does not respond to her/his name orfamiliar voices and voice commands; the animal is withdrawn andunwilling to play or otherwise interact (unlike what may be described asa generally aloof behaviour in some felines); it is reluctant or refusesto go for walks (e.g., a canine) or to even go outside despite neverhesitating to do so in its younger years; it does not recognize or isstartled by family members, toys, or other cues that it has beenfamiliar with and exposed to on a constant basis throughout its life; itfrequently trembles or shakes uncontrollably (despite not being exposedto a cold temperature or being unstartled) either while standing orlying down; it paces or wanders aimlessly throughout the house as if itis unfamiliar with its location or environment; it has difficultylearning new tasks, commands, or routes; for canines, sleeping moreduring the day and less during the night; it becomes startled byinterior lighting, the television, and other visual or auditory stimulidespite having been exposed to such on a regular basis throughout itslife; it seeks less and less of the human attention, praise, and play,and is hesitant to take treats, drink fresh water, or eat fresh food.

The development and validation of tests for assessing cognitive functionincluding discrimination, oddity, reversal, and spatial memory has beeninstrumental in documenting age-related cognitive differences and thedeterioration of such function. The associated neurodegenerative changesinclude: reduction in brain mass, increased ventricular size, meningealcalcification, demyelization, neuroaxonal degeneration, reduction inneurons, increased accumulation of diffuse beta amyloid plaques withperivascular infiltrates, depletion of catecholamines, increase inmonoamine oxidase B (MAOB) activity, resulting in a decline in thecholinergic system. Common clinical signs of cognitive decline incompanion pets, such as dogs and cats, are represented by the acronymDISHA (Disorientation, Altered Interactions with people or other pets,Altered Sleep-wake cycles, Housesoiling, Activity changes (initiallydecline then increased restless or repetitive locomotion).

Little is known about the staging and phenotypic variability of CDS, andlittle is known in terms of the prevention and treatment of CDS.

As such, there remains a need for compositions and prophylactictreatment regimens that may improve the overall mental condition ofnon-human animals such as canines and felines, and which may thus delayor otherwise ameliorate a progression of conditions that are associatedwith or seen during the normal course of non-human animal aging.

SUMMARY OF DISCLOSURE

According to various aspects, the present disclosure relates to ahomotaurine-enriched composition for improving a mental condition of anon-human animal, the homotaurine-enriched composition comprisinghomotaurine and one or more edible materials.

According to various aspects, the present disclosure relates to a kitcomprising the homotaurine-enriched composition as defined herein; and adispensing device for dispensing the homotaurine-enriched composition.

According to various aspects, the present disclosure relates to ahomotaurine-enriched supplement for improving a mental condition of anon-human animal, the homotaurine-enriched food supplement comprising aneffective amount of homotaurine homotaurine-enriched composition.

According to various aspects, the present disclosure relates to a kitcomprising: the homotaurine-enriched supplement as defined herein; and adispensing device for dispensing the homotaurine-enriched composition.

According to various aspects, the present disclosure relates to the useof a homotaurine or a homotaurine-enriched composition for improving amental condition of a non-human animal.

According to various aspects, the present disclosure relates to the useof a homotaurine or a homotaurine-enriched composition for delayingonset of neurological conditions associated with aging of a non-humananimal.

According to various aspects, the present disclosure relates to the useof a homotaurine or a homotaurine-enriched composition for preventionand/or treatment of dementia is a non-human animal.

According to various aspects, the present disclosure relates to the useof homotaurine or a homotaurine-enriched composition for evaluatingefficacy of a candidate compound and/or a veterinary candidateformulation and/or veterinary candidate edible materials in theprevention and/or treatment of CDS in a non-human animal.

According to various aspects, the present disclosure relates to the useof a homotaurine-enriched supplement for improving a mental condition ofa non-human animal.

According to various aspects, the present disclosure relates to the useof a homotaurine-enriched supplement for delaying onset of neurologicalconditions associated with aging of a non-human animal.

According to various aspects, the present disclosure relates to the useof a homotaurine-enriched supplement for prevention and/or treatment ofdementia is a non-human animal.

According to various aspects, the present disclosure relates to the useof homotaurine-enriched supplement for evaluating efficacy of acandidate compound and/or a veterinary candidate formulation and/orveterinary candidate edible materials in the prevention and/or treatmentof cognitive dysfunction syndrome (CDS) in a non-human animal.

According to various aspects, the present disclosure relates to a methodfor improving a mental condition of a non-human animal, the methodcomprising administering an effective amount of a homotaurine or ahomotaurine-enriched composition to a non-human animal in need thereof.

According to various aspects, the present disclosure relates to a methodfor delaying onset of neurological conditions associated with aging of anon-human animal, the method comprising administering an effectiveamount of a homotaurine or a homotaurine-enriched composition to anon-human animal in need thereof.

According to various aspects, the present disclosure relates to a methodfor prevention and/or treatment of dementia is a non-human animal, themethod comprising administering an effective amount of a homotaurine ora homotaurine-enriched composition to a non-human animal in needthereof.

According to various aspects, the present disclosure relates to the useof an effective amount of homotaurine for prevention or treatment ofcognitive dysfunction syndrome (CDS) in a non-human animal, wherein theeffective amount of homotaurine is between about 1 g/day and about 5g/day, between about 500 mg/day and about 5 g/day, between about 500mg/day and about 2 g/day, between about 500 mg/day and about 1 g/day,between about 250 mg/day and about 500 mg/day, between about 50 mg/dayand about 100 mg/day, between about 10 mg/day and about 50 mg/day, orbetween about 10 mg/day and about 25 mg/day.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph showing the percentage of aged dogs who received acomposition according to one embodiment of the present disclosure andpassed the learning test.

FIG. 2 is a graph showing the average number of wrong tries in thelearning test of aged dogs who received a composition according to oneembodiment of the present disclosure.

DETAILED DESCRIPTION

The present disclosure stems from the discovery that administration innon-human animals of homotaurine may be effective as a prophylaxis foravoiding or delaying onset of brain deterioration and loss of mentaland/or other cognitive functions, and may be effective for improving thegeneral mental condition and/or general brain function of non-humananimals.

In some embodiments, homotaurine and compositions comprising homotaurineas defined herein may be useful to achieve one or more of the following:i) improvement of the overall mental wellness and/or the overall mentalhealth of a non-human animal; ii) improvement and/or protection of thebrain structure and/or function in a non-human animal; and iii) delay ofthe onset of and/or treatment of CDS.

As used herein, the term “preventing” or “prevention” or “prophylaxis”refers at least to the reduction of likelihood of the risk of (orsusceptibility to) acquiring a disease, disorder or condition (i.e.,causing at least one of the clinical symptoms of the disease, disorderor condition not to develop, or slow down or delay onset, in a non-humananimal that may be exposed to or predisposed to the disease but does notyet experience or display symptoms of the disease).

As used herein, the term “treating” or “treatment” of any disease,disorder or condition refer, in some embodiments, to ameliorating thedisease, disorder or condition (i.e., arresting or reducing thedevelopment of the disease or at least one of the clinical symptomsthereof). In certain instances, “treating” or “treatment” refers toameliorating at least one physical parameter, which may or may not bediscernible by the non-human animal. In certain instances, “treating” or“treatment” refers to inhibiting the disease, disorder or condition,either physically (e.g., stabilization of a discernible symptom),physiologically (e.g., stabilization of a physical parameter), or both.In certain instances, “treating” or “treatment” refers to delaying theonset of the disease, disorder or condition. The term “treating” refersto any indicia of success in the treatment or amelioration of an injury,pathology or condition, including any objective or parameter such asabatement; remission; diminishing of symptoms or making the injury,pathology or condition more tolerable to the non-human animal; slowingin the rate of degeneration or decline, making the final point ofdegeneration less debilitating; improving a non-human animal's physicalor mental well-being; improving and/or preserving memory and cognitivefunctions; restoring and/or improving mental alertness or, in somesituations, preventing the onset of dementia.

In some embodiments, homotaurine and compositions comprising homotaurineas defined herein may be useful for protecting the brain structure, forpreserving memory, for sustaining brain cell health in a non-humananimal.

In some other embodiments, homotaurine and compositions comprisinghomotaurine as defined herein may be useful for prevention and/ortreatment of CDS in a non-human animal.

The present disclosure also relates to the use of homotaurine andcompositions comprising homotaurine for providing neuroprotection to anon-human animal comprising administering to the animal an effectiveamount of homotaurine or compositions comprising homotaurine as definedherein, such that neuroprotection is provided to the animal.

The present disclosure further relates to the use of homotaurine andcompositions comprising homotaurine as defined herein in the treatmentor prevention of inflammation in the brain, neuronal cell toxicity,neuronal cell death or neuronal cell loss in a non-human animal having acondition or disease in which Aβ amyloidogenic proteins or peptides arepresent, or being susceptible or predisposed to said condition ordisease, including a disease or condition characterized by Aβdeposition, as well as in the treatment or prevention of diseases andconditions that may be equivalent to maladies in humans such asAlzheimer's disease, cerebral amyloid angiopathy, Down's syndrome, andother human maladies that are manifested in a manner equivalent tocognitive dysfunction syndrome occurring in a non-human animal.

As used herein, the expression “non-human animal” includes, but is notlimited to, a canine species, a feline species, a rodent species, or anungulate species. In some instances, the canine species is a breed ofcanine that is selected from a large-size companion breed, amedium-sized companion breed or a small-sized companion breed of dog. Insome instances, the breed of canine is a pure-breed dog. In someinstances, the feline species is selected from a companion felinespecies. In some instances, the rodent species is selected from a mouse,a rat, a hamster, or a ferret. In some instances, the ungulate speciesis selected from a bovine, an equine, a porcine, or an ovis or ovineanimal. Examples of non-human animal also include but are not limitedto, pigs, horses, sheeps, goats, cows, birds, rabbits, apes (e.g.,monkeys, chimpanzee, and the like) and the like.

In some embodiments, the non-human animal is a companion animal. Theexpression “companion animal” used in the present disclosure includesany non-human animal suitable for being kept as a pet by humansincluding without limitation, a dog, a cat, rabbit and a rodent. Theterm “dog” includes those dogs which are companion animals such as Canisfamiliaris, working dogs and the like. The term dog is synonymous withthe term canine. The term “cat” includes those cats which are companionanimals known as domestic cats or house cats, or Felis domesticus. Theterm cat is synonymous with the term feline.

As used herein, the term “homotaurine” and equivalent expressions refersto 3-amino-1-propanesulfonic acid, its zwitterionic form (inner salt),and salts and solvates thereof. The homotaurine may be of natural source(extracted or purified from a natural source, e.g. a seaweed) or may besynthetic (e.g. prepared synthetically on site or provided by acommercial source). The term further includes natural extractscontaining at least 10%, at least 20%, at least 30%, at least 40%, atleast 50%, at least 60%, at least 70%, at least 80%, at least 85%, atleast 90%, at least 95%, at least 98%, or at least 99% of homotaurine inthe dried extract. In general, the homotaurine may be hydrated orsolvated. The homotaurinemay exist in multiple crystalline or amorphousforms.

A “nutraceutically acceptable salt”, “acceptable salt” or “suitablesalt” of a compound means a salt of a compound that is acceptable fornon-human animal consumption. Desirable salts of a compound, forexample, will retain or improve the biological and/or chemical and/orphysical properties of the free acid of homotaurine as defined herein,and will not be biologically or otherwise undesirable. Salts includebase addition salts formed by the replacement of the acidic proton ofthe sulfonic acid of homotaurine by, for example, a metal ion,including, an alkali metal ion (e.g., lithium, sodium, potassium), analkaline earth ion (e.g., magnesium, calcium, barium), or other metalions such as aluminum, zinc, iron and the like; or by an organic basesuch as ammonia, ethylamine, diethylamme, ethylenediamine, ethanolamine,diethanolamine, triethanolamine, tromethamine, N-methylglucamine,piperazine, chloroprocain, procain, quaternary ammoniums (e.g.L-carnitine, L-carnitine alkanoyl derivatives such as acetyl, propionyland butyryl-L-carnitine, choline, choline derivatives such asacetylcholine, butyrylcholine, propionylcholine, other aliphatic estersof choline, fatty acid esters of choline such as eicosapentaenoyl (EPA),docosahexaenoyl (DHA), docosapentaenoyl (DPA), capryloyl, lauroyl,myristoyl, palmytoyl, stearoyl, oleoyl, ricinoleoyl, linoleoyl,alpha-linolenoyl, and arachidonoyl, phosphorylcholine,phosphatidylcholines, trimethylglycine, and the like), amino acids (e.g.L-arginine, L-lysine, histidine, and the like), amine-containing orpolyamine compounds (e.g., putrescine, spermidine, spermine,galanthamine, dimethylaminoethanol, and the like), vitamins having abasic group (e.g., vitamins B1 (thiamine), B2 (riboflavin), B3 (niacinor nicotinic acid), B4 (adenine), B6 (pyridoxine), B12 (cobalamine),vitamin U (S-methylmethionine) or folic acid), alkaloids (e.g.,huperzine A and tetrandnne), and the like.

Acceptable salts may be prepared from the parent agent by conventionalchemical methods. Generally, such salts are prepared by reacting thefree base forms of the counterion with a stoichiometric amount of theacid form of homotaurine (or its zwitterion) in water or in an organicsolvent, or in a mixture of the two. Salts may be prepared in situ,during the final isolation or purification of the agent or by separatelyreacting homotaurine in its free acid or zwitterion form with thedesired corresponding base, and isolating the salt thus formed.

All acid, salt, base, and other ionic and non-ionic forms of homotaurineare included in the described compositions, formulation, methods anduses of the present disclosure. For example, if homotaurine is shown asan acid herein, its salt and zwitterionic forms are also included.Likewise, if homotaurine is shown as a salt, the acid and/orzwitterionic forms are also included.

The expression “reduction of side effects of homotaurine” refers todecreasing the amount of or severity of one or more side effects ofhomotaurine by, e.g., 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%,95%, 99%, or 99.9%, or even 100%, which decrease is with respect to theamount of or severity of a side effect of homotaurine that is exhibitedwhen the same equivalent molar dose of homotaurine is administeredorally in water solution or in an immediate release solid formulation (eg. lose-filled capsules).

“Nutraceutically acceptable” or simply “acceptable” associated with aterm such as salts, inert ingredients, carriers, excipients, additives,ingredients, etc., refers to salts, inert ingredients, carriers,excipients, additives, ingredients, etc., suitable for use in contactwith the tissues of non-human animals without undue toxicity,incompatibility, instability, irritation, and the like, commensuratewith a reasonable benefit/risk ratio.

“Acceptable vehicle” or “nutraceutically acceptable vehicle” andequivalent expressions refer to a diluent, adjuvant, excipient, orcarrier with which a material is administered.

In general, the term “composition” and equivalent expressions refer toan enriched/supplemented materials of the present disclosure in a formready for administration or for consumption. The term compositionequally includes, for example, nutraceutical compositions, foodadditives and food preparations (foodstuffs). The expressions“nutraceutical”, “nutraceutical composition”, “dietary supplement” or“dietary composition”, “food supplement”, “nutritional composition” or“nutritional supplement” and equivalent expressions refer to anenriched/supplemented material of the present disclosure, optionally incombination with at least one nutraceutically acceptable vehicle, in aform suitable for administration of the material and compound therein toa non-human animal, e.g., tablets, capsules, etc. The expression “foodadditive” refers to an enriched/supplemented edible material of thepresent description in a form ready to be used in the preparation offoodstuffs, such as powders to be added in the process of making foods,or as a ready-to-use powder form to be added to prepared food or feed.The terms “foodstuff”, “food compositions” or “food preparations” refersto an enriched/supplemented edible material of the present disclosure ina form that can be consumed, for example, eaten, drank, or ingested by anon-human animal.

In some embodiments of the present disclosure, homotaurine may bereplaced by homotaurine analogs. As used herein, the expression“homotaurine analogs” includes any homotaurine analogs that retain theactivity of homotaurine as defined herein. The homotaurine analogsuseful in the compositions and methods of the present disclosure canachieve one or more of the following: i) improvement of the overallmental wellness and/or the overall mental health of a non-human animal;ii) improvement and/or protection of the brain structure and/or functionin a non-human animal; and iii) delay of the onset of and/or to treatCDS. It will be understood that homotaurine analogs are compounds thathave structural similarity with homotaurine but differ by at least onestructural element. Examples of homotaurine analogs include, but are notlimited to, taltrimide, calcium acamprosate and tauromustine.

In some embodiments of the present disclosure, the homotaurine is in aform suitable for administration to a non-human animal (e.g, powder,pills, caplets, liquid, gel, cream, spray, or the like). In someinstances, the homotaurine is a form suitable for oral, intravenous,subcutaneous, transdermal, topical, buccal, sublingual, nasal,inhalation, pulmonary, or parenteral delivery according to conventionalmethods known in the art. In some specific embodiments, homotaurine isin a form suitable for oral administration or consumption (e.g, liquid,powder, capsule, pill, or the like).

As used herein the expressions “effective amount” or “nutraceuticallyeffective amount” refers to the amount of enriched/supplemented materialor composition or its content in homotaurine, upon single or multipleadministration to or consumption by the non-human animal, which providesthe desired effect to the non-human animal. An effective amount can bereadily determined by the use of known techniques and/or by observingresults obtained under analogous circumstances. In determining theeffective amount administered, a number of factors are considered,including, but not limited to the size, age, and general health of thenon-human animal, the specific disease or condition involved, thedegree, involvement, or severity of the disease or condition theresponse of the individual non-human animal, the mode of administration,the bioavailability characteristics of the preparation administered, theuse of concomitant medication, and other relevant circumstances. Theeffective amount refers to an amount of the material, composition orfood preparation or its content in homotaurine to obtain significantbenefit to the non-human animal, either by providing neuroprotection,protecting memory function, protecting the brain structure associatedwith memory and learning, by preserving memory, by sustaining brain cellhealth, by maintaining cognitive functions in the non-human animal. Theexpression “lessening metabolism of homotaurine” (or related terms suchas reduction, less, lowering, reducing, lowered, etc.) refers todecreasing the degree or amount of first-pass metabolism in the GI tractor liver of homotaurine by e.g., 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%,80%, 90%, 95%, 99%, or even 100%, which decrease is with respect to thedegree or amount of metabolism of homotaurine that occurs when the sameequivalent molar dose of homotaurine is administered orally in a watersolution.

Amounts of homotaurine to be administered to the non-human animal in anadministration regimen may include a per dose amount in a gram ormilligram range or lesser amounts of homotaurine (in the compositions ofthe present disclosure) per kilogram of the non-human animal dependingon the species, breed, age and size of the non-human animal. Amounts ofhomotaurine to be administered to the non-human animal in dosingadministration regimen may be calculated on a basis of the non-animalweight (e.g., about 50 micrograms per kilogram to about 500 milligramsper kilogram, about 1 milligram per kilogram to about 200 milligrams perkilogram, about 1 milligram per kilogram to about 100 milligrams perkilogram, about 1 milligram per kilogram to about 50 milligram perkilogram, about 1 milligram per kilogram to about 10 milligrams perkilogram, or about 3 milligrams per kilogram to about 5 milligrams perkilogram).

Additional examples of doses of homotaurine, depending on the species,breed, age and size of the non-human animal, may include doses ofbetween about 1 gram and about 5 g, between about 500 mg and about 2 g,between about 500 mg and about 1 g, between about 200 mg and about 500mg, between about 200 mg and about 250 mg, between about 25 mg and about200 mg, between about 5 mg and about 500 mg, between about 25 mg andabout 300 mg, between about 50 mg to about 150 mg, between about 10 mgand about 100 mg, between about 20 mg and about 75 mg, between about 10mg and about 50 mg, about 5 g, about 4 g, about 3 g, about 2 g, about 1g, about 500 mg, about 250 mg, about 100 mg, about 50 mg, or about 10mg, preferably, once daily or twice daily.

Additional examples of doses of homotaurine, depending on the species,breed, age and size of the non-human animal, may include doses ofbetween about 1 g/day and about 5 g/day, between about 500 mg/day andabout 5 g/day, between about 500 mg/day and about 2 g/day, between about500 mg/day and about 1 g/day, between about 250 mg/day and about 500mg/day, between about 50 mg/day and about 100 mg/day, between about 10mg/day and about 50 mg/day, or between about 10 mg/day and about 25mg/day.

For comparison, examples of doses for homotaurine per se can includebetween about 200-500 miligram of homotaurin per kilogram of non-humananimal (once daily), between about 100-250 milligram of homotaurin perkilogram of non-human animal (once daily), between about 10-50 milligramof homotaurin per kilogram of non-human animal (once daily), betweenabout 1-2 milligram of homotaurine per kilogram of non-human animal(twice daily) or between about 4-6 milligram of homotaurine per kilogramof the non-human animal (daily).

A person skilled in the art will appreciate that the effective amount ofhomotaurine to be administered depends on the type of a non-human animalinto which the homotaurine is to be administered and/or the physicalsize of the non-human animal and/or the age of the non-human animal.

In some embodiments, homotaurine may be administered directly to thenon-human animals. That is to say that, in such embodiments, homotaurineis not mixed with any other materials prior to being administered to thenon-human animals.

In some other embodiments however, homotaurine may be mixed with oradded to other materials prior to administration to the non-humananimals to form a homotaurine-enriched composition. Thehomotaurine-enriched composition when given or administered to thenon-human animals may provide prophylaxis of mental deterioration of thenon-human animal and may improve the overall mental wellness and/or theoverall mental health of a non-human animal.

As used herein, the expression “homotaurine-enriched composition” or“homotaurine-supplemented composition” and equivalent expressions refersto a composition in which the content in homotaurine is higher than thecontent naturally occurring in the sum of the other materials of thecomposition. Prior to enrichment/supplementation, the materials' contentin homotaurine does not amount to an effective amount of homotaurine.

In some embodiments, the composition of the present disclosure comprisesbetween about 0.1% and about 60%, 0.2% and about 60%, between about 0.1%and about 50%, between about 0.1% and about 10%, between about 0.5% andabout 50%, between about 1% and about 40%, between about 1% and about20%, between about 1% and about 10%, between about 10% and about 40%,between about 10% and about 30%, or between about 20% and about 40% ofhomotaurine by weight of the composition.

In some other embodiments, the composition of the present disclosurecomprises between about 0.001% and about 15%, of homotaurine by weightof the composition on a dry matter basis. In some other instances, thecomposition comprises less than about 60%, less than about 50%, lessthan about 40%, less than about 30%, less than about 25%, less thanabout 15%, less than about 10%, less than about 5%, less than about 2%,less than about 1%, less than about 0.5%, less than about 0.2%, lessthan about 0.1%, less than about 0.01%, less than about 0.001% ofhomotaurine by weight of the composition on a dry matter basis.

As indicated above, the compositions of the present disclosure maycomprise materials other than homotaurine (i.e., additional materials).In the instances where the composition is for oral administration, theadditional materials may be edible materials and homotaurine may bemixed or added to one or more edible materials.

In some instances, the additional materials are present in thecomposition at an amount of between about 40% and about 99.8%, betweenabout 50% and about 99.5%, between about 60% and about 99% between about80% and about 99%, between about 90% and about 99%, between about 60%and about 90%, between about 70% and about 90%, or between about 60% andabout 80% by weight of the composition.

Examples of additional edible materials include, but are not limited toa protein source, a carbohydrate source, a fat source, a vegetablesource, a vitamin source, balancing agents and the like. Examples ofproteins sources, carbohydrate sources, fat sources, vitamin sources,minerals sources, balancing agents, and the like, suitable for inclusionin the compositions of the present disclosure may be selected from amongthose conventional materials known to those of ordinary skill in theart.

Proteins useful as ingredients of the compositions of the presentdisclosure include, but are not limited to, meat protein isolate, wheyprotein isolate, mixtures thereof, and the like, as well as vegetablesources, such as soy protein isolate, corn, wheat gluten, mixturesthereof, and the like. Additional sources of protein may include one ormore of the following: animal proteins, including mammalian, avianprotein, reptilian, amphibian, fish, invertebrate proteins andcombinations thereof; e.g., from any of cattle, sheep, pig, goat, deer,rabbit, horse, kangaroo, their milk, curds, whey or blood, and internaltissues and organs such as smooth muscle, striate muscle, liver, kidney,intestine or heart; additional avian protein sources encompass turkey,goose, duck, ostrich, quail, pigeon, their eggs and internal tissues andorgans such as smooth muscle, striate muscle, liver, kidney, intestineor heart; amphibian sources include frog or salamander, reptilianprotein sources include alligator, lizard, turtle and snake; a fishprotein sources include catfish, herring, salmon, tuna, bluefish, cod,halibut, trout, swordfish and their eggs; and an invertebrate proteinsources include lobster, crab, clams, mussels or oysters, andcombinations thereof

Carbohydrate components of the compositions of the present disclosuremay, in addition to one or more of brown rice and oat groats, be fromany source, and may enter the food composition as part of anotheringredient, such as the protein source. In certain embodiments,carbohydrates useful as ingredients of the food compositions of thepresent invention include polysaccharides (e.g., starches and dextrins)and sugars (e.g., sucrose, lactose, maltose, glucose, and fructose) thatare metabolized for energy when hydrolyzed. Examples of additionalcarbohydrate sources suitable for inclusion in the compositionsdisclosed herein include, but are not limited to, corn, whole yellowcorn, grain sorghum, wheat, barley, and rice.

Fats useful as ingredients of the compositions of the present disclosuremay be from any source, such as but not limited to poultry fat, beeftallow, lard, choice white grease, soybean oil, corn oil, canola oil,sunflower oil, mixtures thereof, and the like. The fat may beincorporated completely within the food composition, deposited on theoutside of the food composition, or a mixture of the two methods.

In other embodiments, the composition of the present disclosure is anutritionally complete diet for a companion animal, e.g., a canine or afeline companion animal. In a specific aspect of this embodiment, thecomposition is a food product and the food product is a nutritionallycomplete diet formulated for a canine or feline companion animal.

In other embodiments, the homotaurine to be administered is formulatedand prepared as a supplement. Supplements include, for example, a foodproduct, feed, or pet food, that can be used with another food product,feed, or pet food composition to improve the nutritive balance orperformance of the total. Contemplated supplements include compositionsthat are fed undiluted as a supplement to other feeds or pet foods,offered free choice with other parts of a non-human animal's ration thatare separately available, or diluted and mixed with a non-human animal'sregular feed or pet food to produce a complete feed or pet food.Supplements may be in various forms including, for example, powders,liquids, syrups, pills, encapsulated compositions, sprays, or the like.

In some embodiments of the present disclosure, homotaurine may be usedin combination with at least one other component that is effective inthe prevention and/or treatment of CDS. Such other or second componentmay include, but is not limited to, a monoamine oxidase inhibitor suchas, but not limited to, Selegiline™ (licensed in North America fortreatment of cognitive dysfunction syndrome in dogs). Other componentsthat may be considered include, L-deprenyl hydrochloride,phosphatidylserine, pyridoxine, S-adenosyl-L-methionine, flavonoids,Ginko biloba extract, resveratrol and δ-alpha-tocopherol, botanicaloils, medium-chain triglycerides (MCT), memantine, amantadine,adranafil, modafinil, vitamin E, vitamin A, Senilife™ (which is acombination of phosphatidylserine, pyridoxine, Gingko biloba extract,resveratrol and δ-alpha-tocopherol), Neutricks™ (which containsapoaequorin, a substance derived from jellyfish). Other supplements mayalso be considered to be used in combination with homotaurine, such ascoconut oil, omega-3 fatty acids and Gingko biloba.

Selegiline is a monoamine oxidase B inhibitor that may improve the signsof CDS by enhancing dopamine and other catecholamines in the cortex andhippocampus and by decreasing free radical load.

Propentofylline, which is licensed in Europe and Australia for thetreatment of dullness, lethargy, and depressed demeanor in old dogs, mayincrease blood flow and inhibit platelet aggregation and thrombusformation.

A number of natural products, including diets and supplements, have alsobeen shown to have beneficial effects in improving the signs andpotentially slowing cognitive decline. Two such diets are Canine b/d®,which is supplemented with fatty acids, antioxidants, andDL-alpha-lipoic acid and L-carnitine to enhance mitochondrial function,and a specialized Purina One® diet that uses botanic oils containingmedium-chain triglycerides to provide ketone bodies as an alternativesource of energy for aging neurons.

Other natural supplements that have demonstrated efficacy in improvingcognitive function include Activait®, which contains phosphatidylserinein combination with α-lipoic acid, carnitine, fatty acids, glutathione,and other antioxidants; S-adenosyl-L-methionine (Novifit); andapoaequorin (Neutricks®), a calcium-buffering protein found injellyfish. In some instances, any of the aforementioned diets andsupplements may be combined with a composition or formulation of thepresent disclosure for administration to the non-human animal in orderto provide for the prophylaxis of mental deterioration of the non-humananimal and to improve the overall mental wellness and/or the overallmental health of the non-human animal.

In some embodiments, homotaurine may be absorbed into the ediblematerial which is to be fed to the non-human animals.

The compositions of the present disclosure, which are to be administeredto non-human animals, may be prepared as food products suitable forconsumption by the non-human animals. These food products may be of anyconsistency or moisture content; i.e., the compositions of the presentinvention may be moist, semi-moist, or dry food products. “Moist” foodproducts are generally those with moisture content of from 60% to 90% orgreater. “Dry” food products are generally those with a moisture contentof from 3% to 11%, and are often manufactured in the form of smallpieces or kibbles. “Semi-moist” food products generally have a moisturecontent of from 25% to 35%.

In certain embodiments, the food products may be prepared in a canned orwet form using conventional food preparation processes known to those ofordinary skill in the art.

In other embodiments, the food products may be prepared in a dry formusing convention processes known to those of ordinary skill in the art.

In preparing a composition as defined in the present disclosure, anymaterial generally may be incorporated into the composition during theprocessing of the formulation, e.g., during and/or after mixing of theother materials of the composition. Distribution of these materials intothe composition can be accomplished by conventional means. In certainembodiments, ground animal and/or poultry proteinaceous tissues aremixed with other ingredients, including nutritional balancing agents,inorganic salts, and may further include cellulose, bulking agents andthe like, along with sufficient water for processing.

In particular embodiments, the compositions are formulated so as to beeasier to chew. In specific embodiments, the compositions and foodproducts are formulated to address specific nutritional differencesbetween species and breeds of animals, as well as one of more of theattributes of the animal. For example, canine and feline foods, forexample, are typically formulated based upon the life stage, age, size,weight, body composition, and breed.

In some embodiments, the homotaurine is formulated with materials and/oringredients which together transiently maximizes the degradation and/orthe release of the homotaurine from the edible materials into thestomach and/or the intestine of the non-human animal and transientlymaximises the absorption of the homotaurine by the stomach and/or theintestine of the non-human animal. For example, dried seaweed may behydrated in a solution comprising between about 1 g and about 75 g ofhomotaurine per 100 ml of water, preferably between about 5 g and about50 g per 100 mL of water. The seaweed absorbs part of the homotaurinefrom the solution within or proximate its cells. Theenriched/supplemented seaweed is then optionally dried with or withoutbeing previously rinsed with fresh water. The drying process isaccomplished using any food-processing technique known to the skilled inthe art, e.g. through lyophilization, or heating with or without the useof vacuum.

An homotaurine and the composition comprising homotaurine of the presentdisclosure may also be formulated into an equivalent of a humannutraceutical composition prior to administration using techniques andprocedures well known in the art.

Compositions of the present disclosure for oral administration tonon-human animals may further comprise, without limitation, anynon-allergenic or non-immunogenic carrier or diluent suitable for oraladministration routes to the particular non-human animal species and/orbreed of non-human animal. Such

Compositions of the present disclosure for oral administration may be inthe form of capsules (e.g. hard or soft shell gelatin capsule), tablets,powders, granules, pellets, e.g., coated (e.g., films or entericcoatings) or uncoated, each containing a predetermined amount of amaterial of the present disclosure as an active ingredient.Alternatively, compositions of the present disclosure suitable for oraladministration may be in the form of pre-shaped foodstuff (for example,dried dog or cat food/kibble) that comprises a dosage of homotaurine foreach piece or unit of dried food/kibble and which may be administered tothe non-human animal as part of a daily/weekly/monthly feeding regimenfor the non-human animal. The daily/weekly/monthly feeding regimen maycomprise a schedule of foodstuff weight per feeding to be administeredin order to deliver and maintain an adequate level of homotaurine in thenon-human animal over a period of time during the growth and developmentof the non-human animal and so as to provide for a prophylactictreatment of CDS in the non-human animal.

In solid dosage forms for oral administration, which may be included forexample as an added or an integral part of a foodstuff formulation forthe particular species or breed of a non-human animal of the disclosure,the homotaurine of the present disclosure may be, for example, mixedwith one or more acceptable carriers (depending on the animal healthcare laws, regulations or equivalent provisions of the given country),such as sodium citrate or dicalcium phosphate, or any of the following:fillers or extenders, such as starches, lactose, sucrose, glucose,mannitol, or silicic acid, binders, such as, for example,carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone,sucrose or acacia, humectants, such as glycerol; disintegrating agents,such as agar-agar, calcium carbonate, potato or tapioca starch, alginicacid, certain silicates, and sodium carbonate, solution retarding agentssuch as paraffin, absorption accelerators such as quaternary ammoniumcompounds, wetting agents, such as, for example, cetyl alcohol andglycerol monostearate, absorbents, such as kaolin and bentonite clay,lubricants, such as talc, calcium stearate, magnesium stearate, solidpolyethylene glycols, sodium lauryl sulfate, and mixtures thereof,coloring agents buffering agents and/or flavoring agents.

Prevention of the action of microorganisms can be achieved by variousantibacterial and antifungal agents for example, parabens,chlorobutanol, phenol, ascorbic acid, thimerosal, and the like. Othercompositions useful for attaining systemic delivery of the non-humananimal agents include sublingual and buccal dosage forms. Suchcompositions typically comprise one or more of soluble filler substancessuch as sucrose, sorbitol and mannitol, and binders such as acacia,microcrystalline cellulose, carboxymethyl cellulose and hydroxypropylmethyl cellulose Glidants, lubricants sweeteners, colorants,antioxidants and flavoring agents disclosed above may also be included.Under ordinary conditions of storage and use, these preparations maycontain a preservative to prevent the growth of microorganisms.

The composition of the present disclosure may be packaged as part of akit, optionally including a container (e.g., packaging, a box, a vial,and the like). The kit may comprise the composition as defined hereintogether with instructions on how to use the composition as definedherein. The kit may further comprise a dispensing device for dispensinga suitable amount of the composition as defined herein to the non-humananimal. The dispensing device may be for example, a measuring cup, ameasuring spoon, and the like.

In certain embodiments of the present disclosure, the non-human animalis prognosed to benefit from the methods of the present disclosure, andis selected based on this need. A non-human animal in need includesanimals that have been identified as having CDS or as having a disease,disorder or condition related to β-amyloid deposition (or a depositionof other neurologically damaging molecules, peptides, proteins ormolecular complexes or degradation products that may be associated withan onset and/or progression of CDS (or an equivalent condition) in thenon-human animal), as the non-human animal may be exhibiting a symptomor symptoms of such a disease or disorder, or is at risk of such adisease or disorder due to the breed of the non-human animal, and thusmay be expected, based on a prognosis or diagnosis, to benefit fromtreatment in accordance with the present disclosure (e.g., curing,healing, preventing, alleviating, relieving, altering, remedying,ameliorating, improving, or affecting the disease or disorder, thesymptom of the disease or disorder, or the risk of the disease ordisorder).

Another aspect of the present disclosure pertains to a method forinhibiting neuronal cell death in a non-human animal by administering aneffective amount of a homotaurine enriched/supplemented material orcomposition of formulation of the present disclosure. In yet anotheraspect, the present disclosure pertains to a method for providingneuroprotection to a non-human animal having an Aβ-amyloid-relateddisease or condition which includes the step of administering to (orconsuming by) a non-human animal, an effective amount of a material orcomposition or formulation of the present disclosure, such thatneuroprotection is provided. As used herein, the term “neuroprotection”includes protection of neuronal cells of a non-human animal from celldeath that may result in initiation of processes such as, but notlimited to: the destabilization of the cytoskeleton; DNA fragmentation;the activation of hydrolytic enzymes, such as phospholipase A2;activation of caspases, calcium-activated proteases and/orcalcium-activated endonucleases; inflammation mediated by macrophages;calcium influx into a cell; membrane potential changes in a cell; thedisruption of cell junctions leading to decreased or absent cell-cellcommunication; and the activation of expression of genes involved incell death.

The materials, compositions and formulations of the present disclosuremay act to ameliorate the onset or course of a disease or conditionusing any of the following mechanisms (this list is meant to beillustrative and not limiting): protecting neurons from induced neuronaltoxicity, slowing the rate of β-amyloid fibril formation or depositionand/or the formation or deposition of other neurologically damagingmolecules, peptides, proteins or molecular complexes or degradationproducts that may be associated with an onset and/or progression of CDS(or an equivalent condition) in the non-human animal; lessening thedegree of β-amyloid deposition or deposition of other neurologicallydamaging molecules, peptides, proteins or molecular complexes ordegradation products that may be associated with an onset and/orprogression of CDS (or an equivalent condition) in the non-human animal;inhibiting, reducing, or preventing amyloid or similar fibril formation;inhibiting neurodegeneration or cellular toxicity induced by β-amyloidor other neurologically damaging molecules, peptides, proteins ormolecular complexes or degradation products that may be associated withan onset and/or progression of CDS (or an equivalent condition) in thenon-human animal; inhibiting amyloid-induced inflammation in the brainor brain inflammation induced by other neurologically damagingmolecules, peptides, proteins or molecular complexes or degradationproducts that may be associated with an onset and/or progression of CDS(or an equivalent condition) in the non-human animal; enhancing theclearance of β-amyloid from the brain or the clearance of otherneurologically damaging molecules, peptides, proteins or molecularcomplexes or degradation products that may be associated with an onsetand/or progression of CDS (or an equivalent condition) in the non-humananimal; enhancing degradation of Aβ in the brain or the degradation ofother neurologically damaging molecules, peptides, proteins or molecularcomplexes or degradation products that may be associated with an onsetand/or progression of CDS (or an equivalent condition) in the non-humananimal, or favoring clearance of amyloid protein (or neurologicallydamaging molecules, peptides, proteins or molecular complexes ordegradation products that may be associated with an onset and/orprogression of CDS (or an equivalent condition) in the non-human animal)prior to its of their organization in fibrils, and decreasing the ratioof Aβ42:Aβ40 in the CSF or plasma. As well, as alterations inneurotransmitters can lead to behavior changes such as increasedirritability, agitation, fear, decreased responsiveness to stimuli, andaltered sleep-wake cycles, the materials, compositions and formulationsof the present disclosure may also be helpful in improving the mood andthe behavior related to CDS occurrence as homotaurine can act as a GABAagonist.

In another embodiment, the present disclosure pertains to a method forimproving or preserving cognition function in a non-human animal. Themethod includes administering an effective amount of a material orcomposition or formulation of the present disclosure, such that thenon-human animal's cognition function is improved or preserved.

Improvement or protection of cognition or memory is present within thecontext of the present disclosure if there is a measurable differencebetween the performances of non-human animals treated using the methodsof the present disclosure as compared to members of a placebo grouphistorical control, or a group using a non-enriched/supplementedequivalent material, or between subsequent tests given to the samenon-human animal.

In certain embodiments, compositions of the present disclosure may beadministered concurrently with the administration of at least onetherapeutic or another nutraceutical agent, which can be part of thesame composition as, or in a different composition from, that containingthe materials of the present disclosure. In certain embodiments, thetherapy or dosing administration regimen may comprise alternatingbetween administering a composition or formulation of the presentdisclosure and a composition comprising at least one therapeutic oranother nutraceutical agent, e.g., to minimize adverse side effectsassociated with a particular agent.

In some other embodiments, homotaurine and the compositions comprisinghomotaurine of the present disclosure may be used as a measurableindicator of the efficacy of a candidate compound or a candidatecomposition/formulation or a candidate edible material in improving thegeneral mental condition and/or general brain function of a non-humananimal. In some other embodiments, homotaurine and the compositionscomprising homotaurine of the present disclosure may be used indetermining or assessing the efficacy of a candidate compound or acandidate composition/formulation or a candidate edible material inimproving the general mental condition and/or general brain function ofa non-human animal. In these embodiments, homotaurine and thecompositions comprising homotaurine of the present disclosure may beused as a positive control against which the efficacy of the newcandidate is assessed. In such embodiments, the efficacy of thecandidate compound or a candidate composition/formulation or a candidateedible material in improving the general mental condition and/or generalbrain function of a non-human animal is compared to the efficacy ofhomotaurine or the compositions comprising homotaurine of the presentdisclosure in that same non-human animal. If the efficacy of thecandidate is the same or is higher than the efficacy of the homotaurineor the compositions comprising homotaurine of the present disclosure,than the candidate is shown to improve the general mental conditionand/or general brain function of a non-human animal.

EXAMPLES Example 1: Example of an Operating Protocol in Animal Subjects

The study on animal subjects will be conducted in the following fashion:

-   -   2 groups of older animals, over the age of 10 years, males and        females, each consisting of 15 subjects; a group will be treated        with test product, homotaurine at a dose of 1 g/subject PO SID        (orally, once daily), and one will represent the control group;    -   2 groups of young animals about 5 years of age, males and        females, each consisting of 5 subjects; a group will be treated        with test product, homotaurine at a dose of 1 g/subject PO SID        (orally, once daily), and one will represent the control group.

The opportunity to enlist even younger subjects will be dictated by twofactors: a) verify how learning changes between young animals and olderanimals; and b) check if the supplement as effects only in older animalsor even in young animals.

All subjects will be followed for eight months, with the followingmethodological scheme:

T0: (prior to administration of the test product)

-   -   Specialized clinical examination    -   Behavioral assessment    -   Learning test    -   Blood test (complete blood count, blood chemistry, dopamine        determination, β-amyloid peptides determination)        T1: (after 2 weeks of administration of the test product)    -   Retention test and Reversal learning test        T2: (after 4 months of administration of the test product)    -   Behavioral assessment    -   Learning test        T3: (after 2 weeks from T2)    -   Retention test and Reversal learning test        T4: (after 8 months of administration of the test product)    -   Behavioral assessment    -   Learning test    -   Blood test (complete blood count, blood chemistry, dopamine        determination, β-amyloid peptides determination)        T5: (after 2 weeks from T4)    -   Retention test and Reversal learning test        Behavioral assessment: the behavioral assessment of each dog        will be carried out in order to classify on a scale from 1 to 5        the exploration behavior, the presence of passive behaviors, the        spatial orientation ability, the interaction with people, the        presence/type of vocalizations and the deletions.        Learning test: the learning test will be conducted in a test        apparatus (T-maze). In this test is required to learn which of        the two arm choices results in the correct exit path from the        apparatus. Each dog will be tested until it achieves the        learning criterion of the three consecutive correct trials        within the maximum of 15 attempts.        Retention test: this retention test will be performed 2 weeks        after the learning task with the aim to assess if dogs retained        the acquired information. The dogs will pass the retention test        if entering the correct lateral arm, as acquired during the        learning phase, at least three out of the four trials.        Reversal learning test: this reversal learning test will take        place only if the dog successfully passed the retention test and        immediately after it. This test is intended to evaluate the        dog's ability to contrast and modify previously acquired        behavioral responses. The protocol and learning criterion are        the identical of the learning task, but the arm choice resulting        in a path out of the apparatus is reversed.

The dogs' responses will be monitored in real time using video cameraand the data will be also recorded.

Example 2

The experiment began by selecting two groups of elderly dogs (age morethan 10 years, 16 subjects per group) and two groups of young adult dogs(between 3 and 6 years of age, 6 subjects per group), who were dividedrandomly balancing them per age, seniority, and size.

The dogs underwent a cognitive learning tests (Spatial reversal learningis impaired by aging in pet dogs, P. Mongillo et al., Age, 2013, 35 (6):2273-2282), in a simple maze built to this trial. Passing the testconsisted in the dog's ability to learn to get out of the labyrinth inthe direction that he himself had chosen in the first successfulattempt. The number of attempts has been the test score: the lower thenumber of attempts, better cognitive performance. Immediately after thetest, two groups of dogs (one old and one young) started to receive foodintegration of homotaurine capsules.

Homotaurine at was administered orally once daily (PO SID) at a dose of1 g/subject.

After 15 days the dogs underwent a memory test (learning resultapplication of first test) and, if they have passed the test, to asubsequent reverse learning test, which consisted in learning to exitthe labyrinth from the opposite direction to that previously learnedwithin a defined number of trials.

After 4 months of homotaurine supplementation, initial learning test wasrepeated, with the same modalities of the initial test.

The first evaluable results regarding the comparison between thecognitive learning tests, carried out on two groups of dogs over 10years of age, a period in which aging-correlated brain behavior changescan be observed.

Results of the first test showed that twelve dogshomotaurine-implemented passed the test, and four dogs failed (25% offailures), with an average score (determined as the number of attemptsnecessary) of 6.67, while in the control group of eleven dogs passed thetest and four dogs failed (27% of failures), with an average score of6.36 (FIGS. 1 and 2 and Tables 1 and 2).

TABLE 1 Percentage of the aged dogs able to pass the learning testTreated with homotaurine Controls 1º test 75% 73% 2º test 75% 60%

TABLE 2 Average number of wrong tries of the aged dogs during thelearning test Treated with homotaurine Controls 1º test 6.67 6.36 2ºtest 5.67 6.56

The two groups gave substantially homogeneous results for the firsttest.

During the second test, conducted about four months later,homotaurine-implemented group gave the same results than before (25% offailures), but the average score decreased to 5.67 (−1.0) (FIGS. 1 and 2and Tables 1 and 2).

In the control group, nine dogs passed the test while 6 failed (40% offailures, 13% more than in the first test). Moreover, their averagescore increased to 6.56 (+0.2).

In groups of young dogs (under 6 years of age) it was found a comparabletrend, with a decrease in the average score in homotaurine-implementedgroup (−2.6) and an increase (+1.2) in the control group.

The data presented herein therefore suggests that a homotaurine-enricheddiet in young non-human animals may contribute to delaying the onset ofCDS and in maintaining mental wellness. The data presented herein alsosuggests that ingestion of homotaurine may improve mental condition andlessens ageing effect on the mental functioning of aged non-humananimals.

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, numerous equivalents to thespecific procedures, embodiments, claims, and examples described herein.Such equivalents are considered to be within the scope of thisdisclosure and covered by the claims appended hereto.

The contents of all references, issued patents, and published patentapplications cited throughout this application are hereby incorporatedby reference.

What is claimed is:
 1. A method for treatment of cognitive dysfunctionsyndrome (CDS) in a non-human animal, the method comprisingadministering an effective amount of a homotaurine, ahomotaurine-enriched composition, or a homotaurine-enriched supplementto a non-human animal in need thereof; wherein the effective amount ofhomotaurine is between about 500 mg/day and about 5 g/day.
 2. The methodas defined in claim 1, wherein the homotaurine is3-amino-1-propanesulfonic acid, a salt thereof, a zwitterionic formthereof, a solvate thereof or an analog thereof.
 3. The method asdefined in claim 1, further comprising administering one or more of amonoamine oxidase inhibitor, L-deprenyl hydrochloride,phosphatidylserine, pyridoxine, S-adenosyl-L-methionine, apoaequorin,flavonoids, ginko biloba extract, resveratrol and d-alpha-tocopherol,botanical oils, medium-chain triglycerides, memantine, amantadine,adranafil, modafinil, vitamin E, vitamin A, Senilife, Neutricks, coconutoil, Omega-3 fatty acids, Propentofylline, Canine b/d, antioxidants,DL-alpha-lipoic acid, L-carnitine, botanic oils, Activait®, a-lipoicacid, carnitine, glutathione, and S-adenosyl-L-methionine.
 4. The methodas defined in claim 1, wherein the effective amount of homotaurine isbetween about 1 g/day and about 5 g/day, between about 500 mg/day andabout 2 g/day, between about 500 mg/day and about 1 g/day.
 5. The methodas defined in claim 1, wherein the non-human animal is a canine.
 6. Themethod as defined in claim 5, wherein the canine is a dog.
 7. The methodas defined in claim 1, wherein the homotaurine-enriched compositioncomprises: i) homotaurine; and ii) one or more edible materials.
 8. Themethod as defined in claim 7, wherein the homotaurine is3-amino-1-propanesulfonic acid, a salt thereof, a zwitterionic formthereof, a solvate thereof or an analog thereof.
 9. The method asdefined in claim 7, wherein the homotaurine-enriched composition is fororal administration.
 10. The method as defined in claim 7, wherein thehomotaurine-enriched composition is food for the non-human animal. 11.The method as defined in claim 7, wherein the homotaurine is in anamount of between about 0.1% and about 60%, 0.2% and about 60%, betweenabout 0.1% and about 50%, between about 0.1% and about 10%, betweenabout 0.5% and about 50%, between about 1% and about 40%, between about1% and about 20%, between about 1% and about 10%, between about 10% andabout 40%, between about 10% and about 30%, or between about 20% andabout 40%.
 12. The method as defined in claim 7, wherein the one or moreedible materials is one or more of a protein source, a carbohydratesource, a fat source, a vegetable source, a vitamin source and abalancing agent.
 13. The method as defined in claim 7, wherein thehomotaurine-enriched composition is a nutritionally complete diet forthe non-human animal.
 14. The method as defined in claim 7, wherein thehomotaurine-enriched composition is a nutritionally complete diet for anaged non-human animal.
 15. The method as defined in claim 1, wherein thehomotaurine-enriched supplement comprises an effective amount of ahomotaurine or the homotaurine-enriched composition of claim 7 and atleast one nutraceutically acceptable vehicle.
 16. The method as definedin claim 15, wherein the homotaurine is 3-amino-1-propanesulfonic acid,a salt thereof, a zwitterionic form thereof, a solvate thereof or ananalog thereof.
 17. The method as defined in claim 15, wherein thehomotaurine-enriched supplement is for oral administration.
 18. Themethod as defined in claim 15, wherein the homotaurine-enrichedsupplement is for use as a supplement to the non-human animal diet. 19.The method as defined in claim 15, wherein the homotaurine is in anamount of between about 1 gram and about 5 g, between about 500 mg andabout 2 g, between about 500 mg and about 1 g, between about 200 mg andabout 500 mg, between about 200 mg and about 250 mg, between about 25 mgand about 200 mg, between about 5 mg and about 500 mg, between about 25mg and about 300 mg, between about 50 mg to about 150 mg, between about10 mg and about 100 mg, between about 20 mg and about 75 mg, betweenabout 10 mg and about 50 mg, about 5 g, about 4 g, about 3 g, about 2 g,about 1 g, about 500 mg, about 250 mg, about 100 mg, about 50 mg, orabout 10 mg.
 20. The method as defined in claim 15, wherein thehomotaurine-enriched supplement is for use once daily or twice daily.